December 19, 2014. We are writing to express our strong concerns about the approval standards considered and the conflicts of interest apparent at the December 5, 2014 FDA meeting of the Anti-Infective Drugs Advisory Committee (AIDAC) regarding a new combination antibiotic product, ceftazidime-avibactam (CAZ-AVI).
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
NCHR Testimony Before the FDA on “Framework for Regulatory Oversight of Laboratory Developed Tests”
January 8, 2015. Our Center has frequently urged the FDA to improve their oversight of medical devices. Despite past criticisms, we believe it is essential that FDA have the authority to regulate laboratory-developed tests in order to stimulate even better science, and help ensure that patients receive the full benefit of our growing scientific knowledge.
Read More »Letters to Congressional Leadership Supporting the Medical Device Excise Tax
January 9, 2015. This is a sample of the letters that were sent to key Democrats and Republicans in the House and Senate in January 2015.
Read More »Comments on Reclassification of Iontophoresis Devices Intended for Any Other Purposes
December 22, 2015. As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the down classification of iontophoresis devices intended for any other purposes from Class III to Class II (special controls).
Read More »Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers
December 15, 2014. We strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. The Cardiovascular Devices Panel stated on March 9, 1979 that these devices should be classified into Class III because the device “provided temporary life-support and that certain kinds of failures could cause this device to emit inappropriate electrical signals, which could cause cardiac irregularities and death.”
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